Update my Qualification Plan Evaluations
Source:vignettes/articles/update-qualification.Rmd
update-qualification.RmdOverview
This tutorial demonstrates how to review and update evaluations in an existing qualification plan without adding or changing project snapshots. This is useful when:
- You want to modify plot configurations
- You need to reorganize report sections
- You’re updating plot assignments or building block references
- You want to add or modify comparison plots (CT, GOF, DDI, PK ratio plots)
- You need to adjust building block or parameter inheritance
This is the most common workflow when maintaining an established qualification plan where the underlying models haven’t changed, but the qualification report structure or evaluations need updates.
We’ll use the qualification plan for UGT1A1- and UGT1A9-mediated drug-drug interactions (DDI) from the Qualification-DDI-UGT repository as our example.
Prerequisites
- The
ospsuite.qualificationplaneditorpackage installed - An existing qualification plan JSON file
- Understanding of what evaluations you want to modify
Workflow Overview
Updating a qualification plan involves:
- Load the qualification plan: Convert the existing plan to Excel
- Edit evaluations: Modify plot configurations, sections, and assignments
- Convert back to JSON: Generate the updated qualification plan
- Test and validate: Run the updated plan to verify changes
Step 1: Define File Paths
Start by specifying your qualification plan and output files:
# Existing qualification plan (included with package for this example)
qualificationPlan <- "qualification_ugt.json"
# Output Excel file name
excelFile <- "qualification_ugt.xlsx"Note: For your own projects, replace
"qualification_ugt.json" with the path to your
qualification plan. This can be: - A local file path:
"C:/Projects/MyQualification/plan.json" - A GitHub URL:
"https://raw.githubusercontent.com/Org/Repo/main/qualification_plan.json"
Step 2: Convert Qualification Plan to Excel
Convert your qualification plan to Excel format. Notice that we
only provide the qualificationPlan
parameter - we do not provide
snapshotPaths since we’re not adding or changing
projects:
toExcelEditor(
fileName = excelFile,
qualificationPlan = qualificationPlan
)
#>
#> ── Exporting to Excel Editor ───────────────────────────────────────────────────
#> ℹ Copying Excel Template to qualification_ugt.xlsx
#> ✔ Copying Excel Template to qualification_ugt.xlsx [191ms]
#>
#> ℹ Checking for Qualification Plan
#> ℹ Qualification Plan: qualification_ugt.json
#> ℹ Checking for Qualification Plan✔ Checking for Qualification Plan [32ms]
#>
#> ℹ Exporting Projects Data
#> ✔ Exporting Projects Data [63ms]
#>
#> ℹ Exporting Simulation Outputs Data
#> ✔ Exporting Simulation Outputs Data [573ms]
#>
#> ℹ Exporting Simulation Observed Data
#> ✔ Exporting Simulation Observed Data [262ms]
#>
#> ℹ Exporting Observed Data
#> ✔ Exporting Observed Data [30ms]
#>
#> ℹ Exporting Building Block Data
#>
#> ℹ Exporting Building Block Data── Qualification Plan ──
#> ℹ Exporting Building Block Data
#> ℹ Exporting Building Block Data✔ Exporting Building Block Data [289ms]
#>
#> ℹ Exporting Schema Data
#> ✔ Exporting Schema Data [20ms]
#>
#> ℹ Exporting Sections
#> ✔ Exporting Sections [24ms]
#>
#> ℹ Exporting Intro and Inputs
#> ✔ Exporting Intro and Inputs [27ms]
#>
#> ℹ Exporting Simulation Parameters Settings
#> ✔ Exporting Simulation Parameters Settings [26ms]
#>
#> ℹ Exporting All Plots Settings
#> ✔ Exporting All Plots Settings [27ms]
#>
#> ℹ Exporting Comparison Time Profile Plot Settings
#> ✔ Exporting Comparison Time Profile Plot Settings [71ms]
#>
#> ℹ Exporting GOF Merged Plot Settings
#> ✔ Exporting GOF Merged Plot Settings [50ms]
#>
#> ℹ Exporting DDI Ratio Plot Settings
#> ✔ Exporting DDI Ratio Plot Settings [69ms]
#>
#> ℹ Exporting Global Plot Settings
#> ✔ Exporting Global Plot Settings [22ms]
#>
#> ℹ Exporting Global Axes Settings
#> ✔ Exporting Global Axes Settings [43ms]
#>
#> ℹ Saving extracted data into qualification_ugt.xlsx
#> ✔ Saving extracted data into qualification_ugt.xlsx [434ms]What This Does
When you convert without snapshots, the function:
- Reads the qualification plan: Parses the JSON file
-
Extracts all content:
- Projects and their metadata
- All evaluations (plots, sections, inputs)
- Building block and parameter inheritance
- Plot configurations and mappings
- Report structure (sections, introduction)
- Global settings
-
Populates Excel worksheets: Creates editable sheets
for:
- MetaInfo: Schema version
- Projects: All project definitions (read-only, shown in grey)
- Simulations_Outputs: Available outputs (read-only)
- Simulations_ObsData: Observed data links (read-only)
- ObsData: Observed dataset definitions (Type is editable)
- BB: Building block inheritance (fully editable)
- SimParam: Parameter inheritance (fully editable)
- All_Plots: Individual plot evaluations (fully editable)
- CT_Plots/CT_Mapping: Comparison time profile plots (fully editable)
- GOF_Plots/GOF_Mapping: Goodness of fit plots (fully editable)
- DDIRatio_Plots/DDIRatio_Mapping: DDI ratio plots (fully editable)
- PKRatio_Plots/PKRatio_Mapping: PK ratio plots (fully editable)
- Sections: Report section structure (fully editable)
- Intro: Introduction file reference (fully editable)
- Inputs: Building block documentation (fully editable)
- GlobalPlotSettings: Plot appearance settings (fully editable)
- GlobalAxesSettings: Axis configuration (fully editable)
- Lookup: Reference tables (read-only)
-
Applies formatting:
- All projects will be grey (unchanged) since no new snapshots were provided
- Data validation dropdowns are enabled
- Read-only sheets should not be edited; modifying them can cause validation or conversion errors when the Excel file is imported back into the tool
Step 3: Edit the Excel File
Open the Excel file to review and modify evaluations:
utils::browseURL(excelFile)Common Evaluation Updates
Here are the most common types of updates when maintaining a qualification plan:
A. Reorganize Report Sections (Sections sheet)
Add new sections:
Section Reference | Section Title | Parent Section
------------------|-------------------------|---------------
3.1-new | New Results Section | 3-results
3.1.1-subsection | Detailed Analysis | 3.1-newRename or restructure: - Modify section titles for clarity - Change parent-child relationships - Reorder by changing section references
B. Reassign Plots to Different Sections (All_Plots sheet)
Before:
Project | Simulation | Output | Section Reference
---------|------------|--------------|------------------
Project1 | Sim1 | Concentration| 2-methodsAfter (moved to results):
Project | Simulation | Output | Section Reference
---------|------------|--------------|------------------
Project1 | Sim1 | Concentration| 3-resultsOr remove from report (leave section empty):
Project | Simulation | Output | Section Reference
---------|------------|--------------|------------------
Project1 | Sim1 | Concentration| [empty - excluded]C. Modify Comparison Time Profile Plots (CT_Plots and CT_Mapping)
Update plot properties (CT_Plots): - Change axes labels, titles, or descriptions - Modify scaling (linear vs. logarithmic) - Update section assignments - Change plot dimensions
Update plot mappings (CT_Mapping): - Add or remove simulation outputs from plots - Change which observed data is compared - Modify plot groupings
Example - Adding a simulation to an existing plot: In CT_Mapping, add a row:
PlotId | Project | Simulation | Output | ObservedData
-------|----------|------------|--------------|-------------
CT-01 | Project2 | NewSim | Concentration| ObsData-XD. Create or Modify GOF Plots (GOF_Plots and GOF_Mapping)
Goodness of fit plots typically require:
In GOF_Plots: Define the plot with settings
PlotId | Title | Section Reference
---------|--------------------------|------------------
GOF-01 | Model Validation Summary | 3.2-validationIn GOF_Mapping: Map simulation-observation pairs
PlotId | Project | Simulation | Output | ObservedData
-------|----------|------------|--------------|-------------
GOF-01 | Project1 | Sim1 | AUC | Clinical-AUC
GOF-01 | Project1 | Sim2 | Cmax | Clinical-Cmax
GOF-01 | Project2 | Sim3 | AUC | Clinical-AUCE. Configure Building Block Inheritance (BB sheet)
Add inheritance:
Project | BB-Type | BB-Name | Parent-Project
---------|------------|------------|---------------
Project2 | Compound | Drug-A | Project1Remove inheritance (leave Parent-Project empty):
Project | BB-Type | BB-Name | Parent-Project
---------|------------|------------|---------------
Project2 | Compound | Drug-A | [empty]F. Update Parameter Inheritance (SimParam sheet)
Specify parameter inheritance between simulations:
Project | Parent Project | Parent Simulation | TargetSimulation | Path
---------|----------------|-------------------|------------------|-----
Project2 | Project1 | Sim-Control | Sim-DDI | Organism|*|ParameterG. Add Building Block Documentation (Inputs sheet)
Include building block details in report:
Project | BB-Type | BB-Name | Section Reference
---------|------------|--------------|------------------
Project1 | Compound | Verapamil | 2.1-compounds
Project1 | Individual | European-Pop | 2.2-populationsExcel Content
| Qualification.plan.schema.version |
|---|
| 3.3 |
| Project | Simulation | Output |
|---|---|---|
| Mefenamic_acid | PO MD 500 mg loading / 250 mg every 6 h | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) |
| Mefenamic_acid | PO SD 250 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) |
| Mefenamic_acid | PO SD 500 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | IV 0.08 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO SD 5 mg IC tablet (Chang 2015) (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 250 mg fed (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO SD 250 mg fed (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO SD 10 mg IC tablet (Chang 2015) (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine |
| Raltegravir | Raltegravir 800 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 10 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 100 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 1200 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 1600 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 200 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 25 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 50 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 400mg chewable fasted | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 400mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 100 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 200 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 400 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 400mg (granules in suspension) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Raltegravir | Raltegravir 400mg chewable fed | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Atazanavir | Acosta2007_300mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | Agarwala2003_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | Agarwala2005a_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | Agarwala2005b_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | Martin2008_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | Zhu2011_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungFemales | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-028_200mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-028_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-040_200mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-040_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-040_800mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-056_300mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-076_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-076_800mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | Zhu2010_300mg_Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-004_400mg_TreatmentA | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine |
| Atazanavir | FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Control - Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) |
| Project | Simulation | ObservedData |
|---|---|---|
| Mefenamic_acid | PO SD 250 mg | Rouini 2005 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12) |
| Mefenamic_acid | PO SD 250 mg | Mahadik 2012 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12) |
| Mefenamic_acid | PO SD 250 mg | Hamaguchi 1987 - Treatment 2 - fasted with 200 mL of water - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=4) |
| Mefenamic_acid | PO SD 500 mg | Goosen 2017 - 500 mg SD - Mefenamic acid - PO - 500 mg - Plasma - agg. |
| Dapagliflozin | IV 0.08 mg (perm) | Boulton 2013 - 14C-dapagliflozin iv - Dapagliflozin - IV - 0.08 mg - Plasma - agg. (n=7) |
| Dapagliflozin | PO SD 10 mg (perm) | Boulton 2013 - Dapagliflozin po - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=7) |
| Dapagliflozin | PO SD 10 mg (perm) | Imamura 2013 - Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=22) |
| Dapagliflozin | PO SD 10 mg (perm) | Kasichayanula 2011a - fasted - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) |
| Dapagliflozin | PO SD 10 mg (perm) | Kasichayanula 2013a - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) |
| Dapagliflozin | PO SD 10 mg (perm) | Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) |
| Dapagliflozin | PO SD 10 mg (perm) | Vakkalagadda 2016 - Dapagliflozin - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=42) |
| Dapagliflozin | PO SD 10 mg (perm) | Kasichayanula 2011c - Healthy Volunteers - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 10 mg (perm) | Komoroski 2009 - SAD 10 mg - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 10 mg (perm) | Komoroski 2009 - SAD 10 mg (Urine) - Dapagliflozin - PO - 10 mg - Urine - agg. (n=6) |
| Dapagliflozin | PO SD 10 mg (perm) | Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 50 mg (perm) | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) |
| Dapagliflozin | PO SD 50 mg (perm) | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) |
| Dapagliflozin | PO SD 50 mg (perm) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) |
| Dapagliflozin | PO SD 50 mg (perm) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) |
| Dapagliflozin | PO SD 50 mg (perm) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) |
| Dapagliflozin | PO SD 50 mg (perm) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) |
| Dapagliflozin | PO SD 50 mg (perm) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) |
| Dapagliflozin | PO SD 50 mg (perm) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) |
| Dapagliflozin | PO SD 50 mg (perm) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) |
| Dapagliflozin | PO SD 50 mg (perm) | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 50 mg (perm) | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) |
| Dapagliflozin | PO SD 50 mg (perm) | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 2.5 mg (perm) | Komoroski 2009 - SAD 2.5 mg - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 2.5 mg (perm) | Komoroski 2009 - SAD 2.5 mg (Urine) - Dapagliflozin - PO - 2.5 mg - Urine - agg. (n=6) |
| Dapagliflozin | PO SD 2.5 mg (perm) | Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 5 mg (perm) | Komoroski 2009 - SAD 5 mg - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 5 mg (perm) | Komoroski 2009 - SAD 5 mg (Urine) - Dapagliflozin - PO - 5 mg - Urine - agg. (n=6) |
| Dapagliflozin | PO SD 20 mg (perm) | Kasichayanula 2012 - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=24) |
| Dapagliflozin | PO SD 20 mg (perm) | Komoroski 2009 - SAD 20 mg - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 20 mg (perm) | Komoroski 2009 - SAD 20 mg (Urine) - Dapagliflozin - PO - 20 mg - Urine - agg. (n=6) |
| Dapagliflozin | PO SD 20 mg (perm) | Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 20 mg (perm) | Kasichayanula 2011b - Study 2: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) |
| Dapagliflozin | PO SD 20 mg (perm) | Kasichayanula 2011b - Study 3: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) |
| Dapagliflozin | PO SD 100 mg (perm) | Komoroski 2009 - SAD 100 mg - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 100 mg (perm) | Komoroski 2009 - SAD 100 mg (Urine) - Dapagliflozin - PO - 100 mg - Urine - agg. (n=6) |
| Dapagliflozin | PO SD 100 mg (perm) | Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 250 mg (perm) | Komoroski 2009 - SAD 250 mg fasted - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 250 mg (perm) | Komoroski 2009 - SAD 250 mg fasted (Urine) - Dapagliflozin - PO - 250 mg - Urine - agg. (n=6) |
| Dapagliflozin | PO SD 500 mg (perm) | Komoroski 2009 - SAD 500 mg - Dapagliflozin - PO - 500 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 500 mg (perm) | Komoroski 2009 - SAD 500 mg (Urine) - Dapagliflozin - PO - 500 mg - Urine - agg. (n=6) |
| Dapagliflozin | PO SD 5 mg IC tablet (Chang 2015) (perm) | Chang 2015 - Study 1 Treatment A (single oral doses) - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=36) |
| Dapagliflozin | PO SD 250 mg fed (perm) | Komoroski 2009 - SAD 250 mg fed - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO SD 10 mg IC tablet (Chang 2015) (perm) | Chang 2015 - Study 2 Treatment A (single oral doses) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=36) |
| Dapagliflozin | PO MD 10 mg (perm) | Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO MD 10 mg (perm) | Komoroski 2009 - MAD 10 mg (day 7 and day 14) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO MD 100 mg (perm) | Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO MD 100 mg (perm) | Komoroski 2009 - MAD 100 mg (day 7 and day 14) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO MD 2.5 mg (perm) | Komoroski 2009 - MAD 2.5 mg (day 7 and day 14) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO MD 2.5 mg (perm) | Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO MD 20 mg (perm) | Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO MD 20 mg (perm) | Komoroski 2009 - MAD 20 mg (day 7 and day 14) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO MD 50 mg (perm) | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) |
| Dapagliflozin | PO MD 50 mg (perm) | Komoroski 2009 - MAD 50 mg (day 7 and day 14) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) |
| Raltegravir | Raltegravir 800 mg (lactose formulation) | Iwamoto 2008 - 800mg - Raltegravir - PO - 800 mg - Plasma - agg. (n=24) |
| Raltegravir | Raltegravir 10 mg (lactose formulation) | Iwamoto 2008 - 10mg - Raltegravir - PO - 10 mg - Plasma - agg. (n=24) |
| Raltegravir | Raltegravir 100 mg (lactose formulation) | Iwamoto 2008 - 100mg - Raltegravir - PO - 100 mg - Plasma - agg. (n=24) |
| Raltegravir | Raltegravir 1200 mg (lactose formulation) | Iwamoto 2008 - 1200mg - Raltegravir - PO - 1200 mg - Plasma - agg. (n=24) |
| Raltegravir | Raltegravir 1600 mg (lactose formulation) | Iwamoto 2008 - 1600mg - Raltegravir - PO - 1600 mg - Plasma - agg. (n=24) |
| Raltegravir | Raltegravir 200 mg (lactose formulation) | Iwamoto 2008 - 200mg - Raltegravir - PO - 200 mg - Plasma - agg. (n=24) |
| Raltegravir | Raltegravir 25 mg (lactose formulation) | Iwamoto 2008 - 25mg - Raltegravir - PO - 25 mg - Plasma - agg. (n=24) |
| Raltegravir | Raltegravir 50 mg (lactose formulation) | Iwamoto 2008 - 50mg - Raltegravir - PO - 50 mg - Plasma - agg. (n=24) |
| Raltegravir | Raltegravir 400mg chewable fasted | Rhee 2014 - Chewable tablet fasted - Raltegravir - po - 400 mg - Plasma - agg. (n=12) |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Rhee 2014 - filmcoated tablet - Raltegravir - po - 400 mg - Plasma - agg. (n=12) |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Wenning 2009 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=10) |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Iwamoto 2008 - 400mg FCT - Raltegravir - PO - 400 mg - Plasma - agg. (n=14) |
| Raltegravir | Raltegravir 400mg (lactose formulation) | Iwamoto 2008 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=24) |
| Raltegravir | Raltegravir 100 mg filmcoated tablet md | Markowitz 2006 - 100mg FCT MD - Raltegravir - PO - 100 mg - Plasma - agg. (n=7) |
| Raltegravir | Raltegravir 200 mg filmcoated tablet md | Markowitz 2006 - 200mg FCT MD - Raltegravir - PO - 200 mg - Plasma - agg. (n=7) |
| Raltegravir | Raltegravir 200 mg filmcoated tablet md | Kassahun 2007 - 200mg FCT SD - Raltegravir - PO - 200 mg - Plasma - agg. (n=8) |
| Raltegravir | Raltegravir 400 mg filmcoated tablet md | Markowitz 2006 - 400mg FCT MD - Raltegravir - PO - 400 mg - Plasma - agg. (n=6) |
| Raltegravir | Raltegravir 400mg (granules in suspension) | Rhee 2014 - granules suspension - Raltegravir - po - 400 mg - Plasma - agg. (n=12) |
| Raltegravir | Raltegravir 400mg chewable fed | Rhee 2014 - Chewable tablet fed - Raltegravir - po - 400 mg - Plasma - agg. (n=12) |
| Atazanavir | Acosta2007_300mg | Acosta 2007 - Period 1 - Atazanavir - PO - 300 mg - Plasma - agg. (n=10) |
| Atazanavir | Agarwala2003_400mg | Agarwala 2003 - Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=65) |
| Atazanavir | Agarwala2005a_400mg | Agarwala 2005a - ATV 400 mg AM (N=15) - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) |
| Atazanavir | Agarwala2005b_400mg | Agarwala 2005b - ATV 400 mg (Treatment A) - Atazanavir - PO - 400 mg - Plasma - agg. (n=16) |
| Atazanavir | Martin2008_400mg | Martin 2008 - Atazanavir monotherapy (n = 24) - Atazanavir - PO - 400 mg - Plasma - agg. (n=24) |
| Atazanavir | Zhu2011_400mg | Zhu 2011 - Treatment A: Atazanavir 400 mg QPM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28) |
| Atazanavir | Zhu2011_400mg | Zhu 2011 - Treatment B: Atazanavir 400 mg QAM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28) |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungFemales | ClinPharmReview, AI424-014, p. 77 - Young Females - Atazanavir - PO - 400 mg - Plasma - agg. (n=14) |
| Atazanavir | FDA-ClinPharmReview_AI424-028_200mg | ClinPharmReview, AI424-028, p. 128 - A-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8) |
| Atazanavir | FDA-ClinPharmReview_AI424-028_200mg | ClinPharmReview, AI424-028, p. 128 - B-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8) |
| Atazanavir | FDA-ClinPharmReview_AI424-028_400mg | ClinPharmReview, AI424-028, p. 128 - C-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8) |
| Atazanavir | FDA-ClinPharmReview_AI424-028_400mg | ClinPharmReview, AI424-028, p. 128 - D-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8) |
| Atazanavir | FDA-ClinPharmReview_AI424-040_200mg | ClinPharmReview, AI424-040, p. 64 - 200 mg - Atazanavir - PO - 200 mg - Plasma - agg. (n=20) |
| Atazanavir | FDA-ClinPharmReview_AI424-040_400mg | ClinPharmReview, AI424-040, p. 64 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=20) |
| Atazanavir | FDA-ClinPharmReview_AI424-040_800mg | ClinPharmReview, AI424-040, p. 64 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=20) |
| Atazanavir | FDA-ClinPharmReview_AI424-056_300mg | ClinPharmReview, AI424-056, p. 134 - Atazanavir without ritonavir, Day 10 - Atazanavir - PO - 300 mg - Plasma - agg. (n=30) |
| Atazanavir | FDA-ClinPharmReview_AI424-076_400mg | ClinPharmReview, AI424-076, p. 178 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=65) |
| Atazanavir | FDA-ClinPharmReview_AI424-076_800mg | ClinPharmReview, AI424-076, p. 178 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=66) |
| Atazanavir | Zhu2010_300mg_Atazanavir | Zhu 2010 - Atazanvir 300 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=22) |
| Atazanavir | FDA-ClinPharmReview_AI424-004_400mg_TreatmentA | ClinPharmReview, AI424-004, p. 94 - Treatment A - Atazanavir - PO - 400 mg - Plasma - agg. (n=32) |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | ClinPharmReview, AI424-029, p. 47 - Urinary radioactivity - Atazanavir - PO - 400 - Urine - agg. (n=12) |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | ClinPharmReview, AI424-014, p. 77 - Young Males - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) |
| Atazanavir | FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects | ClinPharmReview, AI424-015, p. 81 - Normal subjects - Atazanavir - PO - 400 mg - Plasma - agg. (n=16) |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Control - Dapagliflozin - Kasichayanula 2013a | Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | Kasichayanula 2013a - Study 2: with Perpetrator (Mefenamic Acid) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir | Neely 2010 - Study arm A (Raltegravir 400mg BID) - Raltegravir - PO - 400 mg - Plasma - agg. (n=20) |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | Neely 2010 - Study arm B (Raltegravir 400mg OD + Atazanavir 400 mg OD) - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir | Iwamoto 2008 - Study I, Period 1 (control) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | Iwamoto 2008 - Study I, Period 2 (ATV treatment) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir | Krishna 2016 - Period 1, Day 1 (1200 mg raltegravir SD) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=14) |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | Krishna 2016 - Period 2, Day 7 (1200 mg raltegravir SD with OD doses of 400 mg ATV) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=12) |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir | Zhu 2010 - Raltegravir 400 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=22) |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Zhu 2010 - Raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Zhu 2010 - Atazanvir 300 mg twice daily plus raltegravir 400 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=19) |
| Id | Path | Type |
|---|---|---|
| DDI Ratios | https://raw.githubusercontent.com/Open-Systems-Pharmacology/Database-for-observed-data/v1.7/DDI.csv | DDIRatio |
| Project | BB-Type | BB-Name | Parent-Project |
|---|---|---|---|
| Mefenamic_acid-Dapagliflozin-DDI | Individual | Standard_Adult_UGT | Dapagliflozin |
| Mefenamic_acid-Dapagliflozin-DDI | Compound | Mefenamic acid | Mefenamic_acid |
| Mefenamic_acid-Dapagliflozin-DDI | Compound | Dapagliflozin | Dapagliflozin |
| Mefenamic_acid-Dapagliflozin-DDI | Formulation | Ponstan capsule | Mefenamic_acid |
| Atazanavir-Raltegravir-DDI | Compound | Raltegravir | Raltegravir |
| Atazanavir-Raltegravir-DDI | Compound | Atazanavir | Atazanavir |
| Atazanavir-Raltegravir-DDI | Formulation | Reyataz capsule | Atazanavir |
| Atazanavir-Raltegravir-DDI | Formulation | filmcoated tablet (original Merck formulation) | Raltegravir |
| Mefenamic_acid | Individual | Standard_Adult | |
| Mefenamic_acid | Compound | Mefenamic acid | |
| Mefenamic_acid | Protocol | PO MD 500 mg loading / 250 mg every 6 h | |
| Mefenamic_acid | Protocol | 250 mg SD | |
| Mefenamic_acid | Protocol | 500 mg SD | |
| Mefenamic_acid | Event | breakfast | |
| Mefenamic_acid | Event | snack (MEFA) | |
| Mefenamic_acid | Formulation | Ponstan capsule | |
| Dapagliflozin | Individual | Standard_Adult_UGT | |
| Dapagliflozin | Compound | Dapagliflozin | |
| Dapagliflozin | Protocol | IV 0.08 mg | |
| Dapagliflozin | Protocol | PO SD 50 mg | |
| Dapagliflozin | Protocol | PO SD 2.5 mg | |
| Dapagliflozin | Protocol | PO SD 5 mg | |
| Dapagliflozin | Protocol | PO SD 10 mg | |
| Dapagliflozin | Protocol | PO SD 20 mg | |
| Dapagliflozin | Protocol | PO SD 100 mg | |
| Dapagliflozin | Protocol | PO SD 250 mg | |
| Dapagliflozin | Protocol | PO SD 500 mg | |
| Dapagliflozin | Protocol | PO MD 2.5 mg | |
| Dapagliflozin | Protocol | PO MD 10 mg | |
| Dapagliflozin | Protocol | PO MD 20 mg | |
| Dapagliflozin | Protocol | PO MD 50 mg | |
| Dapagliflozin | Protocol | PO MD 100 mg | |
| Dapagliflozin | Event | breakfast | |
| Dapagliflozin | Formulation | Dissolved | |
| Dapagliflozin | Formulation | IC tablet (Chang 2015) | |
| Raltegravir | Individual | Standard European Male for PEQ | |
| Raltegravir | Compound | Raltegravir | |
| Raltegravir | Protocol | Iwamoto 2008 400mg PO (Figure 1) omeprazole study | |
| Raltegravir | Protocol | Iwamoto 2008 10mg PO (Figure 2) Safety-Tolerability-PK study | |
| Raltegravir | Protocol | Iwamoto 2008 25mg PO (Figure 2) Safety-Tolerability-PK study | |
| Raltegravir | Protocol | Iwamoto 2008 50mg PO (Figure 2) Safety-Tolerability-PK study | |
| Raltegravir | Protocol | Iwamoto 2008 100mg PO (Figure 2) Safety-Tolerability-PK study | |
| Raltegravir | Protocol | Iwamoto 2008 200mg PO (Figure 2) Safety-Tolerability-PK study | |
| Raltegravir | Protocol | Iwamoto 2008 800mg PO (Figure 2) Safety-Tolerability-PK study | |
| Raltegravir | Protocol | Iwamoto 2008 1200mg PO (Figure 2) Safety-Tolerability-PK study | |
| Raltegravir | Protocol | Iwamoto 2008 1600mg PO (Figure 2) Safety-Tolerability-PK study | |
| Raltegravir | Protocol | Markowitz 2006 100mg bid 10d | |
| Raltegravir | Protocol | Markowitz 2006 200mg bid 10d | |
| Raltegravir | Protocol | Markowitz 2006 400mg bid 10d | |
| Raltegravir | Event | Food | |
| Raltegravir | Formulation | Weibull (lactose formulation) | |
| Raltegravir | Formulation | chewable tablet | |
| Raltegravir | Formulation | filmcoated tablet (original Merck formulation) | |
| Raltegravir | Formulation | Weibull (granules) | |
| Atazanavir | Individual | Agarwala2003 | |
| Atazanavir | Individual | Agarwala2005a | |
| Atazanavir | Individual | Agarwala2005b | |
| Atazanavir | Individual | Martin2008 | |
| Atazanavir | Individual | Zhu2011 | |
| Atazanavir | Individual | WhiteAmericanMale | |
| Atazanavir | Individual | WhiteAmericanFemale | |
| Atazanavir | Individual | Zhu2010 | |
| Atazanavir | Individual | Acosta2007 | |
| Atazanavir | Compound | Atazanavir | |
| Atazanavir | Protocol | 400mg_QD_7days | |
| Atazanavir | Protocol | 400mg_QD_6days | |
| Atazanavir | Protocol | 400mg_QD_5days | |
| Atazanavir | Protocol | 200mg_QD_5days | |
| Atazanavir | Protocol | 800mg_QD_5days | |
| Atazanavir | Protocol | 400mg_SD | |
| Atazanavir | Protocol | 300mg_BID_7days_at120h | |
| Atazanavir | Protocol | 300mg_BID | |
| Atazanavir | Protocol | 200mg_QD_6days | |
| Atazanavir | Protocol | 300mg_QD_10days | |
| Atazanavir | Protocol | 800mg_QD_6days | |
| Atazanavir | Event | High-fat breakfast | |
| Atazanavir | Event | Light meal | |
| Atazanavir | Formulation | Reyataz capsule | |
| Mefenamic_acid-Dapagliflozin-DDI | Protocol | Dapagliflozin - PO SD 10 mg | |
| Mefenamic_acid-Dapagliflozin-DDI | Protocol | Mefenamic acid - PO MD 500 mg loading / 250 mg every 6 h | |
| Mefenamic_acid-Dapagliflozin-DDI | Protocol | Dapagliflozin - PO SD 10 mg (with MEFA) | |
| Mefenamic_acid-Dapagliflozin-DDI | Event | snack (MEFA) | |
| Mefenamic_acid-Dapagliflozin-DDI | Formulation | Solution | |
| Atazanavir-Raltegravir-DDI | Individual | Neely2010 | |
| Atazanavir-Raltegravir-DDI | Individual | HispanicMale | |
| Atazanavir-Raltegravir-DDI | Individual | Krishna2016 | |
| Atazanavir-Raltegravir-DDI | Individual | Zhu2010 | |
| Atazanavir-Raltegravir-DDI | Protocol | 400mg_BID_8days | |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_400mg_QD_8days | |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_100mg_at144h | |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_100mg | |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_1200mg | |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_1200mg_at144h | |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_400mg_BID_5days | |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_400mg_BID_14days_at288h | |
| Atazanavir-Raltegravir-DDI | Protocol | 300mg_BID_14days_at288h | |
| Atazanavir-Raltegravir-DDI | Protocol | 400mg_QD_9days | |
| Atazanavir-Raltegravir-DDI | Protocol | 400mg_QD_8days | |
| Atazanavir-Raltegravir-DDI | Event | High-fat breakfast | |
| Atazanavir-Raltegravir-DDI | Event | Light meal |
| Project | Parent.Project | Parent.Simulation | Path | TargetSimulation |
|---|---|---|---|---|
| Mefenamic_acid-Dapagliflozin-DDI | Dapagliflozin | PO SD 10 mg (perm) | Dapagliflozin|logP (veg.oil/water) | DDI Control - Dapagliflozin - Kasichayanula 2013a |
| Mefenamic_acid-Dapagliflozin-DDI | Dapagliflozin | PO SD 10 mg (perm) | Dapagliflozin|logP (veg.oil/water) | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a |
| Mefenamic_acid-Dapagliflozin-DDI | Dapagliflozin | PO SD 10 mg (perm) | Dapagliflozin|Blood/Plasma concentration ratio | DDI Control - Dapagliflozin - Kasichayanula 2013a |
| Mefenamic_acid-Dapagliflozin-DDI | Dapagliflozin | PO SD 10 mg (perm) | Dapagliflozin|Blood/Plasma concentration ratio | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a |
| Project | Simulation | Section.Reference |
|---|---|---|
| Raltegravir | tralala | introduction |
| Mefenamic_acid | PO MD 500 mg loading / 250 mg every 6 h | NA |
| Mefenamic_acid | PO SD 250 mg | NA |
| Mefenamic_acid | PO SD 500 mg | NA |
| Dapagliflozin | IV 0.08 mg (perm) | NA |
| Dapagliflozin | PO SD 10 mg (perm) | NA |
| Dapagliflozin | PO SD 10 mg (perm) | NA |
| Dapagliflozin | PO SD 50 mg (perm) | NA |
| Dapagliflozin | PO SD 50 mg (perm) | NA |
| Dapagliflozin | PO SD 50 mg (perm) | NA |
| Dapagliflozin | PO SD 50 mg (perm) | NA |
| Dapagliflozin | PO SD 50 mg (perm) | NA |
| Dapagliflozin | PO SD 50 mg (perm) | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | NA |
| Dapagliflozin | PO SD 5 mg (perm) | NA |
| Dapagliflozin | PO SD 5 mg (perm) | NA |
| Dapagliflozin | PO SD 20 mg (perm) | NA |
| Dapagliflozin | PO SD 20 mg (perm) | NA |
| Dapagliflozin | PO SD 100 mg (perm) | NA |
| Dapagliflozin | PO SD 100 mg (perm) | NA |
| Dapagliflozin | PO SD 250 mg (perm) | NA |
| Dapagliflozin | PO SD 250 mg (perm) | NA |
| Dapagliflozin | PO SD 500 mg (perm) | NA |
| Dapagliflozin | PO SD 500 mg (perm) | NA |
| Dapagliflozin | PO SD 5 mg IC tablet (Chang 2015) (perm) | NA |
| Dapagliflozin | PO SD 250 mg fed (perm) | NA |
| Dapagliflozin | PO SD 250 mg fed (perm) | NA |
| Dapagliflozin | PO SD 10 mg IC tablet (Chang 2015) (perm) | NA |
| Dapagliflozin | PO MD 10 mg (perm) | NA |
| Dapagliflozin | PO MD 10 mg (perm) | NA |
| Dapagliflozin | PO MD 100 mg (perm) | NA |
| Dapagliflozin | PO MD 100 mg (perm) | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | NA |
| Dapagliflozin | PO MD 20 mg (perm) | NA |
| Dapagliflozin | PO MD 20 mg (perm) | NA |
| Dapagliflozin | PO MD 50 mg (perm) | NA |
| Dapagliflozin | PO MD 50 mg (perm) | NA |
| Raltegravir | Raltegravir 800 mg (lactose formulation) | NA |
| Raltegravir | Raltegravir 10 mg (lactose formulation) | NA |
| Raltegravir | Raltegravir 100 mg (lactose formulation) | NA |
| Raltegravir | Raltegravir 1200 mg (lactose formulation) | NA |
| Raltegravir | Raltegravir 1600 mg (lactose formulation) | NA |
| Raltegravir | Raltegravir 200 mg (lactose formulation) | NA |
| Raltegravir | Raltegravir 25 mg (lactose formulation) | NA |
| Raltegravir | Raltegravir 50 mg (lactose formulation) | NA |
| Raltegravir | Raltegravir 400mg chewable fasted | NA |
| Raltegravir | Raltegravir 400mg filmcoated tablet | NA |
| Raltegravir | Raltegravir 400mg (lactose formulation) | NA |
| Raltegravir | Raltegravir 100 mg filmcoated tablet md | NA |
| Raltegravir | Raltegravir 200 mg filmcoated tablet md | NA |
| Raltegravir | Raltegravir 400 mg filmcoated tablet md | NA |
| Raltegravir | Raltegravir 400mg (granules in suspension) | NA |
| Raltegravir | Raltegravir 400mg chewable fed | NA |
| Atazanavir | Acosta2007_300mg | NA |
| Atazanavir | Agarwala2003_400mg | NA |
| Atazanavir | Agarwala2005a_400mg | NA |
| Atazanavir | Agarwala2005b_400mg | NA |
| Atazanavir | Martin2008_400mg | NA |
| Atazanavir | Zhu2011_400mg | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungFemales | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_200mg | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_400mg | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_200mg | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_400mg | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_800mg | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-056_300mg | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-076_400mg | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-076_800mg | NA |
| Atazanavir | Zhu2010_300mg_Atazanavir | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-004_400mg_TreatmentA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects | NA |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Control - Dapagliflozin - Kasichayanula 2013a | NA |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | NA |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | NA |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir | NA |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | NA |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | NA |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir | NA |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | NA |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | NA |
| Title | Section.Reference | Simulation.Duration | TimeUnit | ChartWidth | ChartHeight | AxisSize | LegendSize | OriginSize | FontFamilyName | WatermarkSize | X_Dimension | X_GridLines | X_Scaling | Y_Dimension | Y_GridLines | Y_Scaling |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Iwamoto 2008 | atazanavir-raltegravir-ddi | 176 | h | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Krishna 2016 | atazanavir-raltegravir-ddi | 216 | h | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Neely 2010 | atazanavir-raltegravir-ddi | 192 | h | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Zhu 2010 | atazanavir-raltegravir-ddi | 612 | h | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Kasichayanula 2013a | mefenamic-acid-dapagliflozin-ddi | 48 | h | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Project | Simulation | Output | Observed.data | Plot.Title | StartTime | TimeUnit | Color | Caption | Symbol |
|---|---|---|---|---|---|---|---|---|---|
| Atazanavir | Acosta2007_300mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Acosta 2007 - Period 1 - Atazanavir - PO - 300 mg - Plasma - agg. (n=10) | NA | NA | NA | NA | NA | NA |
| Atazanavir | Agarwala2003_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Agarwala 2003 - Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=65) | NA | NA | NA | NA | NA | NA |
| Atazanavir | Agarwala2005a_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Agarwala 2005a - ATV 400 mg AM (N=15) - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) | NA | NA | NA | NA | NA | NA |
| Atazanavir | Agarwala2005b_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Agarwala 2005b - ATV 400 mg (Treatment A) - Atazanavir - PO - 400 mg - Plasma - agg. (n=16) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-004_400mg_TreatmentA | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-004, p. 94 - Treatment A - Atazanavir - PO - 400 mg - Plasma - agg. (n=32) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungFemales | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-014, p. 77 - Young Females - Atazanavir - PO - 400 mg - Plasma - agg. (n=14) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine | ClinPharmReview, AI424-014, p. 77 - Young Males - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine | ClinPharmReview, AI424-029, p. 47 - Urinary radioactivity - Atazanavir - PO - 400 - Urine - agg. (n=12) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-014, p. 77 - Young Males - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-029, p. 47 - Urinary radioactivity - Atazanavir - PO - 400 - Urine - agg. (n=12) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-015, p. 81 - Normal subjects - Atazanavir - PO - 400 mg - Plasma - agg. (n=16) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_200mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-028, p. 128 - A-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_200mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-028, p. 128 - B-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-028, p. 128 - C-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-028, p. 128 - D-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_200mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-040, p. 64 - 200 mg - Atazanavir - PO - 200 mg - Plasma - agg. (n=20) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-040, p. 64 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=20) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_800mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-040, p. 64 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=20) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-056_300mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-056, p. 134 - Atazanavir without ritonavir, Day 10 - Atazanavir - PO - 300 mg - Plasma - agg. (n=30) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-076_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-076, p. 178 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=65) | NA | NA | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-076_800mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-076, p. 178 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=66) | NA | NA | NA | NA | NA | NA |
| Atazanavir | Martin2008_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Martin 2008 - Atazanavir monotherapy (n = 24) - Atazanavir - PO - 400 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Atazanavir | Zhu2010_300mg_Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Atazanvir 300 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=22) | NA | NA | NA | NA | NA | NA |
| Atazanavir | Zhu2011_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Zhu 2011 - Treatment A: Atazanavir 400 mg QPM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28) | NA | NA | NA | NA | NA | NA |
| Atazanavir | Zhu2011_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Zhu 2011 - Treatment B: Atazanavir 400 mg QAM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28) | NA | NA | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - Study I, Period 1 (control) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) | Iwamoto 2008 | 0 | h | #2166ac | Control (without atazanavir) | Circle |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - Study I, Period 2 (ATV treatment) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) | NA | NA | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - Study I, Period 2 (ATV treatment) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) | Iwamoto 2008 | 144 | h | #b2182b | Treatment (with atazanavir) | Square |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Krishna 2016 - Period 1, Day 1 (1200 mg raltegravir SD) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=14) | Krishna 2016 | 0 | h | #2166ac | Control (without atazanavir) | Circle |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Krishna 2016 - Period 2, Day 7 (1200 mg raltegravir SD with OD doses of 400 mg ATV) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=12) | NA | NA | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Krishna 2016 - Period 2, Day 7 (1200 mg raltegravir SD with OD doses of 400 mg ATV) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=12) | Krishna 2016 | 144 | h | #b2182b | Treatment (with atazanavir) | Square |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Neely 2010 - Study arm A (Raltegravir 400mg BID) - Raltegravir - PO - 400 mg - Plasma - agg. (n=20) | Neely 2010 | 168 | h | #2166ac | Control (without atazanavir) | Circle |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Neely 2010 - Study arm B (Raltegravir 400mg OD + Atazanavir 400 mg OD) - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) | NA | NA | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Neely 2010 - Study arm B (Raltegravir 400mg OD + Atazanavir 400 mg OD) - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) | Neely 2010 | 168 | h | #b2182b | Treatment (with atazanavir) | Square |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Raltegravir 400 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=22) | Zhu 2010 | 96 | h | #2166ac | Control (without atazanavir) | Circle |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Atazanvir 300 mg twice daily plus raltegravir 400 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=19) | NA | NA | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) | NA | NA | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Atazanvir 300 mg twice daily plus raltegravir 400 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=19) | NA | NA | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) | Zhu 2010 | 600 | h | #b2182b | Treatment (with atazanavir) | Square |
| Dapagliflozin | IV 0.08 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Boulton 2013 - 14C-dapagliflozin iv - Dapagliflozin - IV - 0.08 mg - Plasma - agg. (n=7) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 10 mg (day 7 and day 14) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 10 mg (day 7 and day 14) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 100 mg (day 7 and day 14) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 100 mg (day 7 and day 14) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 2.5 mg (day 7 and day 14) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 2.5 mg (day 7 and day 14) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 20 mg (day 7 and day 14) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 20 mg (day 7 and day 14) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 50 mg (day 7 and day 14) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 50 mg (day 7 and day 14) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Boulton 2013 - Dapagliflozin po - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=7) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Imamura 2013 - Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=22) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2011a - fasted - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2011c - Healthy Volunteers - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2013a - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 10 mg (Urine) - Dapagliflozin - PO - 10 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 10 mg - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Vakkalagadda 2016 - Dapagliflozin - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=42) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Boulton 2013 - Dapagliflozin po - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=7) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Imamura 2013 - Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=22) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2011a - fasted - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2011c - Healthy Volunteers - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2013a - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 10 mg (Urine) - Dapagliflozin - PO - 10 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 10 mg - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Vakkalagadda 2016 - Dapagliflozin - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=42) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg IC tablet (Chang 2015) (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Chang 2015 - Study 2 Treatment A (single oral doses) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=36) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 100 mg (Urine) - Dapagliflozin - PO - 100 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 100 mg - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 100 mg (Urine) - Dapagliflozin - PO - 100 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 100 mg - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 2.5 mg (Urine) - Dapagliflozin - PO - 2.5 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 2.5 mg - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 2.5 mg (Urine) - Dapagliflozin - PO - 2.5 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 2.5 mg - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2011b - Study 2: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2011b - Study 3: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2012 - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 20 mg (Urine) - Dapagliflozin - PO - 20 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 20 mg - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2011b - Study 2: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2011b - Study 3: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2012 - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 20 mg (Urine) - Dapagliflozin - PO - 20 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 20 mg - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 250 mg fasted (Urine) - Dapagliflozin - PO - 250 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 250 mg fasted - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 250 mg fasted (Urine) - Dapagliflozin - PO - 250 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 250 mg fasted - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg fed (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 250 mg fed - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg fed (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 250 mg fed - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 5 mg (Urine) - Dapagliflozin - PO - 5 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 5 mg - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 5 mg (Urine) - Dapagliflozin - PO - 5 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 5 mg - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg IC tablet (Chang 2015) (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Chang 2015 - Study 1 Treatment A (single oral doses) - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=36) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 500 mg (Urine) - Dapagliflozin - PO - 500 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 500 mg - Dapagliflozin - PO - 500 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 500 mg (Urine) - Dapagliflozin - PO - 500 mg - Urine - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 500 mg - Dapagliflozin - PO - 500 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Mefenamic_acid | PO MD 500 mg loading / 250 mg every 6 h | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA | NA | NA | NA |
| Mefenamic_acid | PO SD 250 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | Hamaguchi 1987 - Treatment 2 - fasted with 200 mL of water - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=4) | NA | NA | NA | NA | NA | NA |
| Mefenamic_acid | PO SD 250 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | Mahadik 2012 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12) | NA | NA | NA | NA | NA | NA |
| Mefenamic_acid | PO SD 250 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | Rouini 2005 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12) | NA | NA | NA | NA | NA | NA |
| Mefenamic_acid | PO SD 500 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | Goosen 2017 - 500 mg SD - Mefenamic acid - PO - 500 mg - Plasma - agg. | NA | NA | NA | NA | NA | NA |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Control - Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) | Kasichayanula 2013a | 0 | h | #2166ac | Control (without mefenamic acid) | Circle |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2013a - Study 2: with Perpetrator (Mefenamic Acid) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) | Kasichayanula 2013a | 24 | h | #b2182b | Treatment (with mefenamic acid) | Square |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | Kasichayanula 2013a - Study 2: with Perpetrator (Mefenamic Acid) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 10 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 10mg - Raltegravir - PO - 10 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 100 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 100mg - Raltegravir - PO - 100 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 100 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Markowitz 2006 - 100mg FCT MD - Raltegravir - PO - 100 mg - Plasma - agg. (n=7) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 1200 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 1200mg - Raltegravir - PO - 1200 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 1600 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 1600mg - Raltegravir - PO - 1600 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 200 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 200mg - Raltegravir - PO - 200 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 200 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Kassahun 2007 - 200mg FCT SD - Raltegravir - PO - 200 mg - Plasma - agg. (n=8) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 200 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Markowitz 2006 - 200mg FCT MD - Raltegravir - PO - 200 mg - Plasma - agg. (n=7) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 25 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 25mg - Raltegravir - PO - 25 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Markowitz 2006 - 400mg FCT MD - Raltegravir - PO - 400 mg - Plasma - agg. (n=6) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg (granules in suspension) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Rhee 2014 - granules suspension - Raltegravir - po - 400 mg - Plasma - agg. (n=12) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg chewable fasted | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Rhee 2014 - Chewable tablet fasted - Raltegravir - po - 400 mg - Plasma - agg. (n=12) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg chewable fed | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Rhee 2014 - Chewable tablet fed - Raltegravir - po - 400 mg - Plasma - agg. (n=12) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 400mg FCT - Raltegravir - PO - 400 mg - Plasma - agg. (n=14) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Rhee 2014 - filmcoated tablet - Raltegravir - po - 400 mg - Plasma - agg. (n=12) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Wenning 2009 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=10) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 50 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 50mg - Raltegravir - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Raltegravir | Raltegravir 800 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 800mg - Raltegravir - PO - 800 mg - Plasma - agg. (n=24) | NA | NA | NA | NA | NA | NA |
| Title | Section.Reference | Plot.Type | Artifacts | Group.Caption | Group.Symbol | ChartWidth | ChartHeight | AxisSize | LegendSize | OriginSize | FontFamilyName | WatermarkSize | X_Dimension | X_GridLines | X_Scaling | Y_Dimension | Y_GridLines | Y_Scaling |
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| Project | Simulation | Output | Observed.data | Plot.Title | Group.Title | Color |
|---|---|---|---|---|---|---|
| Atazanavir | Acosta2007_300mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Acosta 2007 - Period 1 - Atazanavir - PO - 300 mg - Plasma - agg. (n=10) | NA | NA | NA |
| Atazanavir | Agarwala2003_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Agarwala 2003 - Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=65) | NA | NA | NA |
| Atazanavir | Agarwala2005a_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Agarwala 2005a - ATV 400 mg AM (N=15) - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) | NA | NA | NA |
| Atazanavir | Agarwala2005b_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Agarwala 2005b - ATV 400 mg (Treatment A) - Atazanavir - PO - 400 mg - Plasma - agg. (n=16) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-004_400mg_TreatmentA | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-004, p. 94 - Treatment A - Atazanavir - PO - 400 mg - Plasma - agg. (n=32) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungFemales | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-014, p. 77 - Young Females - Atazanavir - PO - 400 mg - Plasma - agg. (n=14) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine | ClinPharmReview, AI424-014, p. 77 - Young Males - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine | ClinPharmReview, AI424-029, p. 47 - Urinary radioactivity - Atazanavir - PO - 400 - Urine - agg. (n=12) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-014, p. 77 - Young Males - Atazanavir - PO - 400 mg - Plasma - agg. (n=15) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-029, p. 47 - Urinary radioactivity - Atazanavir - PO - 400 - Urine - agg. (n=12) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-015, p. 81 - Normal subjects - Atazanavir - PO - 400 mg - Plasma - agg. (n=16) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_200mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-028, p. 128 - A-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_200mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-028, p. 128 - B-Day 6 - Atazanavir - PO - 200 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-028, p. 128 - C-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-028, p. 128 - D-Day 6 - Atazanavir - PO - 400 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_200mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-040, p. 64 - 200 mg - Atazanavir - PO - 200 mg - Plasma - agg. (n=20) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-040, p. 64 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=20) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_800mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-040, p. 64 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=20) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-056_300mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-056, p. 134 - Atazanavir without ritonavir, Day 10 - Atazanavir - PO - 300 mg - Plasma - agg. (n=30) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-076_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-076, p. 178 - 400 mg - Atazanavir - PO - 400 mg - Plasma - agg. (n=65) | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-076_800mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | ClinPharmReview, AI424-076, p. 178 - 800 mg - Atazanavir - PO - 800 mg - Plasma - agg. (n=66) | NA | NA | NA |
| Atazanavir | Martin2008_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Martin 2008 - Atazanavir monotherapy (n = 24) - Atazanavir - PO - 400 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Atazanavir | Zhu2010_300mg_Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Atazanvir 300 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=22) | NA | NA | NA |
| Atazanavir | Zhu2011_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Zhu 2011 - Treatment A: Atazanavir 400 mg QPM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28) | NA | NA | NA |
| Atazanavir | Zhu2011_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Zhu 2011 - Treatment B: Atazanavir 400 mg QAM - Atazanavir - PO - 400 mg - Plasma - agg. (n=28) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - Study I, Period 1 (control) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - Study I, Period 2 (ATV treatment) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - Study I, Period 2 (ATV treatment) - Raltegravir - PO - 100 mg - Plasma - agg. (n=10) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Krishna 2016 - Period 1, Day 1 (1200 mg raltegravir SD) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=14) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Krishna 2016 - Period 2, Day 7 (1200 mg raltegravir SD with OD doses of 400 mg ATV) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=12) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Krishna 2016 - Period 2, Day 7 (1200 mg raltegravir SD with OD doses of 400 mg ATV) - Raltegravir - PO - 1200 mg - Plasma - agg. (n=12) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Neely 2010 - Study arm A (Raltegravir 400mg BID) - Raltegravir - PO - 400 mg - Plasma - agg. (n=20) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Neely 2010 - Study arm B (Raltegravir 400mg OD + Atazanavir 400 mg OD) - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Neely 2010 - Study arm B (Raltegravir 400mg OD + Atazanavir 400 mg OD) - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Raltegravir 400 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=22) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Atazanvir 300 mg twice daily plus raltegravir 400 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=19) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Atazanvir 300 mg twice daily plus raltegravir 400 mg twice daily - Atazanavir - PO - 300 mg - Plasma - agg. (n=19) | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Zhu 2010 - Raltegravir 400 mg twice daily plus atazanavir 300 mg twice daily - Raltegravir - PO - 400 mg - Plasma - agg. (n=19) | NA | NA | NA |
| Dapagliflozin | IV 0.08 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Boulton 2013 - 14C-dapagliflozin iv - Dapagliflozin - IV - 0.08 mg - Plasma - agg. (n=7) | NA | NA | NA |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 10 mg (day 7 and day 14) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 10 mg (day 7 and day 14) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 100 mg (day 7 and day 14) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 100 mg (day 7 and day 14) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 2.5 mg (day 7 and day 14) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 2.5 mg (day 7 and day 14) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 20 mg (day 7 and day 14) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 20 mg (day 7 and day 14) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 50 mg (day 7 and day 14) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 50 mg (day 7 and day 14) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Boulton 2013 - Dapagliflozin po - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=7) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Imamura 2013 - Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=22) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2011a - fasted - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2011c - Healthy Volunteers - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2013a - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 10 mg (Urine) - Dapagliflozin - PO - 10 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 10 mg - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Vakkalagadda 2016 - Dapagliflozin - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=42) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Boulton 2013 - Dapagliflozin po - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=7) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Imamura 2013 - Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=22) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2011a - fasted - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2011c - Healthy Volunteers - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2013a - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=14) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 10 mg (day 1) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 10 mg (Urine) - Dapagliflozin - PO - 10 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 10 mg - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Vakkalagadda 2016 - Dapagliflozin - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=42) | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg IC tablet (Chang 2015) (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Chang 2015 - Study 2 Treatment A (single oral doses) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=36) | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 100 mg (Urine) - Dapagliflozin - PO - 100 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 100 mg - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 100 mg (day 1) - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 100 mg (Urine) - Dapagliflozin - PO - 100 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 100 mg - Dapagliflozin - PO - 100 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 2.5 mg (Urine) - Dapagliflozin - PO - 2.5 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 2.5 mg - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 2.5 mg (day 1) - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 2.5 mg (Urine) - Dapagliflozin - PO - 2.5 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 2.5 mg - Dapagliflozin - PO - 2.5 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2011b - Study 2: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2011b - Study 3: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2012 - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 20 mg (Urine) - Dapagliflozin - PO - 20 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 20 mg - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2011b - Study 2: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2011b - Study 3: 20 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=18) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2012 - Study 1: Control (Perpetrator Placebo) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 20 mg (day 1) - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 20 mg (Urine) - Dapagliflozin - PO - 20 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 20 mg - Dapagliflozin - PO - 20 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 250 mg fasted (Urine) - Dapagliflozin - PO - 250 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 250 mg fasted - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 250 mg fasted (Urine) - Dapagliflozin - PO - 250 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 250 mg fasted - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg fed (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 250 mg fed - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg fed (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 250 mg fed - Dapagliflozin - PO - 250 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 5 mg (Urine) - Dapagliflozin - PO - 5 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 5 mg - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 5 mg (Urine) - Dapagliflozin - PO - 5 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 5 mg - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg IC tablet (Chang 2015) (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Chang 2015 - Study 1 Treatment A (single oral doses) - Dapagliflozin - PO - 5 mg - Plasma - agg. (n=36) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 2OG Gluc - Dapagliflozin-2-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc (incl. unchanged feces exret.) - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin 3OG Gluc - Dapagliflozin-3-O-glucuronide - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Feces - Dapagliflozin - PO - 50 mg - Feces - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin Urine - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2008 - Mass Balance of 14C-dapagliflozin oxid Metab - Dapagliflozin oxidative metabolites - PO - 50 mg - Fraction - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2011b - Study 1: 50 mg Control (Perpetrator Placebo) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2013b - Healthy subjects with normal kidney function - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - MAD 50 mg (day 1) - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 50 mg (Urine) - Dapagliflozin - PO - 50 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 50 mg - Dapagliflozin - PO - 50 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 500 mg (Urine) - Dapagliflozin - PO - 500 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | Komoroski 2009 - SAD 500 mg - Dapagliflozin - PO - 500 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 500 mg (Urine) - Dapagliflozin - PO - 500 mg - Urine - agg. (n=6) | NA | NA | NA |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Komoroski 2009 - SAD 500 mg - Dapagliflozin - PO - 500 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Mefenamic_acid | PO MD 500 mg loading / 250 mg every 6 h | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Mefenamic_acid | PO SD 250 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | Hamaguchi 1987 - Treatment 2 - fasted with 200 mL of water - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=4) | NA | NA | NA |
| Mefenamic_acid | PO SD 250 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | Mahadik 2012 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12) | NA | NA | NA |
| Mefenamic_acid | PO SD 250 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | Rouini 2005 - Reference - Mefenamic acid - PO - 250 mg - Plasma - agg. (n=12) | NA | NA | NA |
| Mefenamic_acid | PO SD 500 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | Goosen 2017 - 500 mg SD - Mefenamic acid - PO - 500 mg - Plasma - agg. | NA | NA | NA |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Control - Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2013a - Study 2: Control (Perpetrator Placebo) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) | NA | NA | NA |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | Kasichayanula 2013a - Study 2: with Perpetrator (Mefenamic Acid) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) | NA | NA | NA |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | Kasichayanula 2013a - Study 2: with Perpetrator (Mefenamic Acid) - Dapagliflozin - PO - 10 mg - Plasma - agg. (n=16) | NA | NA | NA |
| Raltegravir | Raltegravir 10 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 10mg - Raltegravir - PO - 10 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Raltegravir | Raltegravir 100 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 100mg - Raltegravir - PO - 100 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Raltegravir | Raltegravir 100 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Markowitz 2006 - 100mg FCT MD - Raltegravir - PO - 100 mg - Plasma - agg. (n=7) | NA | NA | NA |
| Raltegravir | Raltegravir 1200 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 1200mg - Raltegravir - PO - 1200 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Raltegravir | Raltegravir 1600 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 1600mg - Raltegravir - PO - 1600 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Raltegravir | Raltegravir 200 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 200mg - Raltegravir - PO - 200 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Raltegravir | Raltegravir 200 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Kassahun 2007 - 200mg FCT SD - Raltegravir - PO - 200 mg - Plasma - agg. (n=8) | NA | NA | NA |
| Raltegravir | Raltegravir 200 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Markowitz 2006 - 200mg FCT MD - Raltegravir - PO - 200 mg - Plasma - agg. (n=7) | NA | NA | NA |
| Raltegravir | Raltegravir 25 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 25mg - Raltegravir - PO - 25 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Raltegravir | Raltegravir 400 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Markowitz 2006 - 400mg FCT MD - Raltegravir - PO - 400 mg - Plasma - agg. (n=6) | NA | NA | NA |
| Raltegravir | Raltegravir 400mg (granules in suspension) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Rhee 2014 - granules suspension - Raltegravir - po - 400 mg - Plasma - agg. (n=12) | NA | NA | NA |
| Raltegravir | Raltegravir 400mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Raltegravir | Raltegravir 400mg chewable fasted | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Rhee 2014 - Chewable tablet fasted - Raltegravir - po - 400 mg - Plasma - agg. (n=12) | NA | NA | NA |
| Raltegravir | Raltegravir 400mg chewable fed | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Rhee 2014 - Chewable tablet fed - Raltegravir - po - 400 mg - Plasma - agg. (n=12) | NA | NA | NA |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 400mg FCT - Raltegravir - PO - 400 mg - Plasma - agg. (n=14) | NA | NA | NA |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Rhee 2014 - filmcoated tablet - Raltegravir - po - 400 mg - Plasma - agg. (n=12) | NA | NA | NA |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Wenning 2009 - 400mg - Raltegravir - PO - 400 mg - Plasma - agg. (n=10) | NA | NA | NA |
| Raltegravir | Raltegravir 50 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 50mg - Raltegravir - PO - 50 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Raltegravir | Raltegravir 800 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | Iwamoto 2008 - 800mg - Raltegravir - PO - 800 mg - Plasma - agg. (n=24) | NA | NA | NA |
| Title | Section.Ref | PK-Parameter | Plot.Type | Subunits | Artifacts | Group.Caption | Group.Color | Group.Symbol | ChartWidth | ChartHeight | AxisSize | LegendSize | OriginSize | FontFamilyName | WatermarkSize | X_Dimension | X_GridLines | X_Scaling | Y_Dimension | Y_GridLines | Y_Scaling |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| UGT1A1 and UGT1A9 Inhibition DDI | qualification-of-ugt-mediated-ddi | AUC | predictedVsObserved | NA | Plot | Atazanavir + Raltegravir | #b2182b | Circle | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| NA | NA | CMAX | residualsVsObserved | NA | GMFE | Mefenamic acid + Dapagliflozin | #2166ac | Square | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | Measure | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | Table | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Project | Simulation_Control | Control.StartTime | Control.EndTime | Control.TimeUnit | Simulation_Treatment | Treatment.StartTime | Treatment.EndTime | Treatment.TimeUnit | Output | Plot.Title | Group.Title | Observed.data | ObsDataRecordID |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir | 0 | 9999 | h | Iwamoto2008_Raltegravir+Atazanavir | 144 | 9999 | h | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | UGT1A1 and UGT1A9 Inhibition DDI | Atazanavir + Raltegravir | DDI Ratios | 571 |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir | 0 | 9999 | h | Krishna2016_Raltegravir+Atazanavir | 144 | 9999 | h | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | UGT1A1 and UGT1A9 Inhibition DDI | Atazanavir + Raltegravir | DDI Ratios | 575 |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir | 168 | 180 | h | Neely2010_Raltegravir+Atazanavir | 168 | 192 | h | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | UGT1A1 and UGT1A9 Inhibition DDI | Atazanavir + Raltegravir | DDI Ratios | 573 |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir | 96 | 108 | h | Zhu2010_Raltegravir+Atazanavir | 600 | 612 | h | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | UGT1A1 and UGT1A9 Inhibition DDI | Atazanavir + Raltegravir | DDI Ratios | 579 |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Control - Dapagliflozin - Kasichayanula 2013a | 0 | 9999 | h | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | 24 | 9999 | h | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | UGT1A1 and UGT1A9 Inhibition DDI | Mefenamic acid + Dapagliflozin | DDI Ratios | 642 |
| Title | Section.Reference | PK-Parameter | Artifacts | Group.Caption | Group.Color | Group.Symbol | ChartWidth | ChartHeight | AxisSize | LegendSize | OriginSize | FontFamilyName | WatermarkSize | X_Dimension | X_GridLines | X_Scaling | Y_Dimension | Y_GridLines | Y_Scaling |
|---|
| Project | Simulation | Output | Plot.Title | Group.Title | Observed.data | ObservedDataRecordId |
|---|---|---|---|---|---|---|
| Atazanavir | Acosta2007_300mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | Agarwala2003_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | Agarwala2005a_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | Agarwala2005b_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-004_400mg_TreatmentA | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungFemales | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|Kidney|Urine|Atazanavir|Fraction excreted to urine | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-014_400mg_YoungMales | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-015_400mg_NormalSubjects | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_200mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-028_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_200mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-040_800mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-056_300mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-076_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | FDA-ClinPharmReview_AI424-076_800mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | Martin2008_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | Zhu2010_300mg_Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir | Zhu2011_400mg | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Iwamoto2008_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Krishna2016_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Neely2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Atazanavir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Atazanavir-Raltegravir-DDI | Zhu2010_Raltegravir+Atazanavir | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | IV 0.08 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO MD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO MD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO MD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO MD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO MD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 10 mg IC tablet (Chang 2015) (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO SD 100 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO SD 2.5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO SD 20 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg fed (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO SD 250 mg fed (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 5 mg IC tablet (Chang 2015) (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-Hepatic-CYP-Optimized Metabolite|Total fraction of dose-Dapagliflozin | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT1A9-Optimized Metabolite|Total fraction of dose-Dapagliflozin | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Dapagliflozin-UGT2B7-Optimized Metabolite|Total fraction of dose-Dapagliflozin | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|Lumen|Feces|Dapagliflozin|Fraction excreted to feces | NA | NA | NA | NA |
| Dapagliflozin | PO SD 50 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|Kidney|Urine|Dapagliflozin|Fraction excreted to urine | NA | NA | NA | NA |
| Dapagliflozin | PO SD 500 mg (perm) | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Mefenamic_acid | PO MD 500 mg loading / 250 mg every 6 h | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Mefenamic_acid | PO SD 250 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Mefenamic_acid | PO SD 500 mg | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Control - Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Dapagliflozin|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Mefenamic_acid-Dapagliflozin-DDI | DDI Treatment - Mefenamic acid/Dapagliflozin - Kasichayanula 2013a | Organism|PeripheralVenousBlood|Mefenamic acid|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 10 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 100 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 100 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 1200 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 1600 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 200 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 200 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 25 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400 mg filmcoated tablet md | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg (granules in suspension) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg chewable fasted | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg chewable fed | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 400mg filmcoated tablet | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 50 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Raltegravir | Raltegravir 800 mg (lactose formulation) | Organism|PeripheralVenousBlood|Raltegravir|Plasma (Peripheral Venous Blood) | NA | NA | NA | NA |
| Section.Reference | Title | Content | Parent.Section |
|---|---|---|---|
| introduction | Introduction | NA | NA |
| objective | Objective | Content/Qualification_DDI_UGT_objective.md | introduction |
| ugt-ddi-network | UGT DDI Network | Content/Qualification_DDI_UGT_network_description.md | introduction |
| network-atazanavir-raltegravir-ddi | Atazanavir - Raltegravir DDI | Content/ATV-RAL-DDI.md | ugt-ddi-network |
| network-mefenamic-acid-dapagliflozin-ddi | Mefenamic acid - Dapagliflozin DDI | Content/MEFA-Dapa-DDI.md | ugt-ddi-network |
| qualification-of-ugt-mediated-ddi | Qualification of Use Case UGT-mediated DDI | Content/Intro_evaluation_DDI_network.md | NA |
| ct-profiles | Concentration-Time Profiles | Content/Intro_evaluation_CTprofiles.md | NA |
| atazanavir-raltegravir-ddi | Atazanavir - Raltegravir DDI | NA | ct-profiles |
| mefenamic-acid-dapagliflozin-ddi | Mefenamic acid - Dapagliflozin DDI | NA | ct-profiles |
| main-references | References | Content/References.md | NA |
| appendix | Appendix | NA | NA |
| osp-introduction | Open Systems Pharmacology Suite (OSPS) Introduction | https://raw.githubusercontent.com/Open-Systems-Pharmacology/Qualification-text-modules/v1.3/OSPS_Introduction.md | appendix |
| mathematical-implementation-of-ddi | Mathematical Implementation of Drug-Drug Interactions | https://raw.githubusercontent.com/Open-Systems-Pharmacology/Qualification-text-modules/v1.3/Mathematical_Implementation_of_DDI.md | appendix |
| automatic-requalification-workflow | Automatic (re)-qualification workflow | https://raw.githubusercontent.com/Open-Systems-Pharmacology/Qualification-text-modules/v1.3/Qualification_Workflow.md | appendix |
| Path |
|---|
| Content/titlepage.md |
| Project | BB-Type | BB-Name | Section.Reference |
|---|---|---|---|
| Mefenamic_acid-Dapagliflozin-DDI | Individual | Standard_Adult_UGT | NA |
| Mefenamic_acid-Dapagliflozin-DDI | Compound | Mefenamic acid | NA |
| Mefenamic_acid-Dapagliflozin-DDI | Compound | Dapagliflozin | NA |
| Mefenamic_acid-Dapagliflozin-DDI | Formulation | Ponstan capsule | NA |
| Atazanavir-Raltegravir-DDI | Compound | Raltegravir | NA |
| Atazanavir-Raltegravir-DDI | Compound | Atazanavir | NA |
| Atazanavir-Raltegravir-DDI | Formulation | Reyataz capsule | NA |
| Atazanavir-Raltegravir-DDI | Formulation | filmcoated tablet (original Merck formulation) | NA |
| Mefenamic_acid | Individual | Standard_Adult | NA |
| Mefenamic_acid | Compound | Mefenamic acid | NA |
| Mefenamic_acid | Protocol | PO MD 500 mg loading / 250 mg every 6 h | NA |
| Mefenamic_acid | Protocol | 250 mg SD | NA |
| Mefenamic_acid | Protocol | 500 mg SD | NA |
| Mefenamic_acid | Event | breakfast | NA |
| Mefenamic_acid | Event | snack (MEFA) | NA |
| Mefenamic_acid | Formulation | Ponstan capsule | NA |
| Dapagliflozin | Individual | Standard_Adult_UGT | NA |
| Dapagliflozin | Compound | Dapagliflozin | NA |
| Dapagliflozin | Protocol | IV 0.08 mg | NA |
| Dapagliflozin | Protocol | PO SD 50 mg | NA |
| Dapagliflozin | Protocol | PO SD 2.5 mg | NA |
| Dapagliflozin | Protocol | PO SD 5 mg | NA |
| Dapagliflozin | Protocol | PO SD 10 mg | NA |
| Dapagliflozin | Protocol | PO SD 20 mg | NA |
| Dapagliflozin | Protocol | PO SD 100 mg | NA |
| Dapagliflozin | Protocol | PO SD 250 mg | NA |
| Dapagliflozin | Protocol | PO SD 500 mg | NA |
| Dapagliflozin | Protocol | PO MD 2.5 mg | NA |
| Dapagliflozin | Protocol | PO MD 10 mg | NA |
| Dapagliflozin | Protocol | PO MD 20 mg | NA |
| Dapagliflozin | Protocol | PO MD 50 mg | NA |
| Dapagliflozin | Protocol | PO MD 100 mg | NA |
| Dapagliflozin | Event | breakfast | NA |
| Dapagliflozin | Formulation | Dissolved | NA |
| Dapagliflozin | Formulation | IC tablet (Chang 2015) | NA |
| Raltegravir | Individual | Standard European Male for PEQ | NA |
| Raltegravir | Compound | Raltegravir | NA |
| Raltegravir | Protocol | Iwamoto 2008 400mg PO (Figure 1) omeprazole study | NA |
| Raltegravir | Protocol | Iwamoto 2008 10mg PO (Figure 2) Safety-Tolerability-PK study | NA |
| Raltegravir | Protocol | Iwamoto 2008 25mg PO (Figure 2) Safety-Tolerability-PK study | NA |
| Raltegravir | Protocol | Iwamoto 2008 50mg PO (Figure 2) Safety-Tolerability-PK study | NA |
| Raltegravir | Protocol | Iwamoto 2008 100mg PO (Figure 2) Safety-Tolerability-PK study | NA |
| Raltegravir | Protocol | Iwamoto 2008 200mg PO (Figure 2) Safety-Tolerability-PK study | NA |
| Raltegravir | Protocol | Iwamoto 2008 800mg PO (Figure 2) Safety-Tolerability-PK study | NA |
| Raltegravir | Protocol | Iwamoto 2008 1200mg PO (Figure 2) Safety-Tolerability-PK study | NA |
| Raltegravir | Protocol | Iwamoto 2008 1600mg PO (Figure 2) Safety-Tolerability-PK study | NA |
| Raltegravir | Protocol | Markowitz 2006 100mg bid 10d | NA |
| Raltegravir | Protocol | Markowitz 2006 200mg bid 10d | NA |
| Raltegravir | Protocol | Markowitz 2006 400mg bid 10d | NA |
| Raltegravir | Event | Food | NA |
| Raltegravir | Formulation | Weibull (lactose formulation) | NA |
| Raltegravir | Formulation | chewable tablet | NA |
| Raltegravir | Formulation | filmcoated tablet (original Merck formulation) | NA |
| Raltegravir | Formulation | Weibull (granules) | NA |
| Atazanavir | Individual | Agarwala2003 | NA |
| Atazanavir | Individual | Agarwala2005a | NA |
| Atazanavir | Individual | Agarwala2005b | NA |
| Atazanavir | Individual | Martin2008 | NA |
| Atazanavir | Individual | Zhu2011 | NA |
| Atazanavir | Individual | WhiteAmericanMale | NA |
| Atazanavir | Individual | WhiteAmericanFemale | NA |
| Atazanavir | Individual | Zhu2010 | NA |
| Atazanavir | Individual | Acosta2007 | NA |
| Atazanavir | Compound | Atazanavir | NA |
| Atazanavir | Protocol | 400mg_QD_7days | NA |
| Atazanavir | Protocol | 400mg_QD_6days | NA |
| Atazanavir | Protocol | 400mg_QD_5days | NA |
| Atazanavir | Protocol | 200mg_QD_5days | NA |
| Atazanavir | Protocol | 800mg_QD_5days | NA |
| Atazanavir | Protocol | 400mg_SD | NA |
| Atazanavir | Protocol | 300mg_BID_7days_at120h | NA |
| Atazanavir | Protocol | 300mg_BID | NA |
| Atazanavir | Protocol | 200mg_QD_6days | NA |
| Atazanavir | Protocol | 300mg_QD_10days | NA |
| Atazanavir | Protocol | 800mg_QD_6days | NA |
| Atazanavir | Event | High-fat breakfast | NA |
| Atazanavir | Event | Light meal | NA |
| Atazanavir | Formulation | Reyataz capsule | NA |
| Mefenamic_acid-Dapagliflozin-DDI | Protocol | Dapagliflozin - PO SD 10 mg | NA |
| Mefenamic_acid-Dapagliflozin-DDI | Protocol | Mefenamic acid - PO MD 500 mg loading / 250 mg every 6 h | NA |
| Mefenamic_acid-Dapagliflozin-DDI | Protocol | Dapagliflozin - PO SD 10 mg (with MEFA) | NA |
| Mefenamic_acid-Dapagliflozin-DDI | Event | snack (MEFA) | NA |
| Mefenamic_acid-Dapagliflozin-DDI | Formulation | Solution | NA |
| Atazanavir-Raltegravir-DDI | Individual | Neely2010 | NA |
| Atazanavir-Raltegravir-DDI | Individual | HispanicMale | NA |
| Atazanavir-Raltegravir-DDI | Individual | Krishna2016 | NA |
| Atazanavir-Raltegravir-DDI | Individual | Zhu2010 | NA |
| Atazanavir-Raltegravir-DDI | Protocol | 400mg_BID_8days | NA |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_400mg_QD_8days | NA |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_100mg_at144h | NA |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_100mg | NA |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_1200mg | NA |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_1200mg_at144h | NA |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_400mg_BID_5days | NA |
| Atazanavir-Raltegravir-DDI | Protocol | Raltegravir_400mg_BID_14days_at288h | NA |
| Atazanavir-Raltegravir-DDI | Protocol | 300mg_BID_14days_at288h | NA |
| Atazanavir-Raltegravir-DDI | Protocol | 400mg_QD_9days | NA |
| Atazanavir-Raltegravir-DDI | Protocol | 400mg_QD_8days | NA |
| Atazanavir-Raltegravir-DDI | Event | High-fat breakfast | NA |
| Atazanavir-Raltegravir-DDI | Event | Light meal | NA |
| ChartWidth | ChartHeight | AxisSize | LegendSize | OriginSize | FontFamilyName | WatermarkSize |
|---|---|---|---|---|---|---|
| 500 | 400 | 11 | 9 | 9 | Arial | 40 |
| Plot | Type | Dimension | Unit | GridLines | Scaling |
|---|---|---|---|---|---|
| GOFMergedPlotsPredictedVsObserved | X | Concentration (mass) | µg/l | FALSE | Log |
| GOFMergedPlotsPredictedVsObserved | Y | Concentration (mass) | µg/l | FALSE | Log |
| GOFMergedPlotsResidualsOverTime | X | Time | h | FALSE | Linear |
| GOFMergedPlotsResidualsOverTime | Y | Dimensionless | FALSE | Linear | |
| DDIRatioPlotsPredictedVsObserved | X | Dimensionless | FALSE | Log | |
| DDIRatioPlotsPredictedVsObserved | Y | Dimensionless | FALSE | Log | |
| DDIRatioPlotsResidualsVsObserved | X | Dimensionless | FALSE | Log | |
| DDIRatioPlotsResidualsVsObserved | Y | Dimensionless | FALSE | Log | |
| ComparisonTimeProfile | X | Time | h | FALSE | Linear |
| ComparisonTimeProfile | Y | Concentration (mass) | ng/ml | FALSE | Log |
| PKRatioPlots | X | Age | year(s) | FALSE | Linear |
| PKRatioPlots | Y | Dimensionless | FALSE | Log |
| BuildingBlock | BuildingBlockOrSimulation | TimeUnit | Symbol | Color | Dimension | Scaling | FontFamilyName | ArtifactsRatioPlots | ArtifactsGOFPlots | subunitsDDIRatioPlots | PK.Parameter | ObservedDataType | GOFMergedPlotType | DDIRatioPlotType | Treatment | Boolean | AxesSettingsPlots |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Individual | Individual | s | Circle | #CC6677 | Age | Linear | Arial | Table | GMFE | Mechanism | AUC | DDIRatio | predictedVsObserved | predictedVsObserved | X | FALSE | GOFMergedPlotsPredictedVsObserved |
| Population | Population | min | Square | #332288 | Amount | Log | Tahoma | GMFE | Plot | Perpetrator | CMAX | PKRatio | residualsOverTime | residualsVsObserved | NA | TRUE | GOFMergedPlotsResidualsOverTime |
| Compound | Compound | h | Diamond | #DDCC77 | Concentration (mass) | NA | TimesNewRoman | Plot | Measure | Victim | C_max | TimeProfile | NA | NA | NA | NA | DDIRatioPlotsPredictedVsObserved |
| Protocol | Protocol | day(s) | Asterisk | #117733 | Concentration (molar) | NA | MicrosoftSansSerif | Measure | NA | NA | C_max_norm | NA | NA | NA | NA | NA | DDIRatioPlotsResidualsVsObserved |
| Event | Event | week(s) | Cross | #88CCEE | Fraction | NA | NA | NA | NA | NA | C_max_tD1_tD2 | NA | NA | NA | NA | NA | ComparisonTimeProfile |
| Formulation | Formulation | month(s) | Triangle | #882255 | Mass | NA | NA | NA | NA | NA | C_max_tD1_tD2_norm | NA | NA | NA | NA | NA | PKRatioPlots |
| ObserverSet | ObserverSet | year(s) | InvertedTriangle | #44AA99 | Time | NA | NA | NA | NA | NA | C_max_tDLast_tEnd | NA | NA | NA | NA | NA | NA |
| ExpressionProfile | ExpressionProfile | NA | Plus | #999933 | Dimensionless | NA | NA | NA | NA | NA | C_max_tDLast_tEnd_norm | NA | NA | NA | NA | NA | NA |
| NA | Simulation | NA | Star | #AA4499 | NA | NA | NA | NA | NA | NA | t_max | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | Pentagon | #DDDDDD | NA | NA | NA | NA | NA | NA | t_max_tD1_tD2 | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | Hexagon | NA | NA | NA | NA | NA | NA | NA | t_max_tDLast_tEnd | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | ThinCross | NA | NA | NA | NA | NA | NA | NA | C_trough_tD2 | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | ThinPlus | NA | NA | NA | NA | NA | NA | NA | C_trough_tDLast | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | CircleOpen | NA | NA | NA | NA | NA | NA | NA | C_tEnd | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | DiamondOpen | NA | NA | NA | NA | NA | NA | NA | AUC_tEnd | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | HexagonOpen | NA | NA | NA | NA | NA | NA | NA | AUC_tEnd_norm | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | InvertedTriangleOpen | NA | NA | NA | NA | NA | NA | NA | AUC_inf | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | PentagonOpen | NA | NA | NA | NA | NA | NA | NA | AUC_inf_norm | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | SquareOpen | NA | NA | NA | NA | NA | NA | NA | AUC_tD1_tD2 | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | StarOpen | NA | NA | NA | NA | NA | NA | NA | AUC_tD1_tD2_norm | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | TriangleOpen | NA | NA | NA | NA | NA | NA | NA | AUC_tDLast_minus_1_tDLast | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | AUC_tDLast_minus_1_tDLast_norm | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | AUC_inf_tD1 | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | AUC_inf_tD1_norm | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | AUC_inf_tDLast | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | AUC_inf_tDLast_norm | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | MRT | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | Thalf | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | Thalf_tDLast_tEnd | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | FractionAucLastToInf | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | CL | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | Vss | NA | NA | NA | NA | NA | NA |
| NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | NA | Vd | NA | NA | NA | NA | NA | NA |
- Use data validation dropdowns: Don’t type free text where dropdowns exist (section references, projects, simulations)
- Check dependencies: If you rename or delete sections, update references to them in plot sheets
- Test incrementally: After major changes, convert to JSON and test before making more edits
- Keep backups: Save a copy before making extensive changes
- Document rationale: Use Excel comments to note why changes were made
- Validate section references: Ensure all section references in evaluation sheets match defined sections
For detailed worksheet descriptions, see the Excel Template Documentation.
Step 4: Convert Back to JSON
After editing, convert the Excel file back to a JSON qualification plan:
excelToQualificationPlan(
excelFile = excelFile,
qualificationPlan = paste0("updated-", qualificationPlan)
)Note: Using
paste0("updated-", qualificationPlan) creates a new file
with an “updated-” prefix, preserving your original. This is recommended
for safety.
Validation Process
The function validates your edits:
- Section references: All references must match sections in the Sections sheet
-
Project/simulation names: Must match definitions in
the
Projects,Simulations_Outputs, andSimulations_ObsDatasheets - Building block references: Parent projects must exist
- Required columns: All mandatory columns must be present
- Lookup values: Values must match allowed options in Lookup sheet
Handling Validation Errors
If validation fails, you’ll see error messages like:
Error: Invalid section reference 'old-section' in All_Plots sheet
Error: Project 'NonExistent' not found in Projects sheet
Error: Missing required column 'Section Reference' in CT_Plots sheetTo fix: 1. Open the Excel file 2. Navigate to the problematic sheet 3. Correct the error (use data validation dropdowns when available) 4. Save and convert again
Next Steps
After updating your qualification plan:
- Run the qualification: Execute with the OSP Suite Qualification Runner
- Review the generated report: Verify changes appear as expected
- Check plots and sections: Ensure evaluations are in the right sections with correct configurations
- Iterate if needed: If further adjustments are required, convert back to Excel and edit again
Common Update Scenarios
Scenario 1: Reorganizing Report Structure
Goal: Move validation results from “Methods” to a new “Validation” section
Steps: 1. In Sections sheet, create new “Validation” section 2. In All_Plots, CT_Plots, GOF_Plots, update Section Reference for validation plots 3. Convert and verify
Scenario 2: Excluding Certain Plots
Goal: Remove specific simulation outputs from the report
Steps: 1. In All_Plots sheet, find the outputs to exclude 2. Clear the Section Reference column for those rows 3. Convert - plots without section references are excluded
Scenario 3: Adding New Comparison Plots
Goal: Create a new CT plot comparing multiple simulations
Steps: 1. In CT_Plots, add a row with unique PlotId and configuration 2. In CT_Mapping, add rows mapping simulations and observed data to this PlotId 3. Assign the plot to a section using Section Reference 4. Convert and test
Troubleshooting
Issue: “Section reference not found”
Cause: You referenced a section that doesn’t exist
Fix: Check the Sections sheet for valid section references and update your references
Issue: “Invalid project name in mapping”
Cause: You typed a project name that doesn’t match the Projects sheet
Fix: Use the data validation dropdown to select from valid projects
Advanced Tips
- Bulk updates: Use Excel’s find-and-replace to update multiple section references at once
- Copy plot configurations: Duplicate rows in plot sheets to create similar plots quickly
- Filter and sort: Use Excel’s filter feature to focus on specific projects or sections
- Conditional formatting: Add your own conditional formatting to highlight specific items
- Freeze panes: Freeze header rows to keep column names visible while scrolling
Related Articles
- Excel Template Documentation: Comprehensive worksheet guide
- Add a Snapshot to Qualification Plan: Adding new projects
- Create Qualification from Snapshot: Starting from scratch